Graft fixation using a plug against suture

ABSTRACT

A method for securing soft tissue to bone which does not require the surgeon to tie suture knots to secure the tissue to the bone. Suture is passed through the graft at desired points. A cannulated plug or screw is pre-loaded onto the distal end of a driver provided with an eyelet implant at its distal end. Suture attached to the graft is passed through the eyelet of the implant located at the distal end of the driver. The distal end of the driver together with the eyelet implant is inserted into the bone. Tension is applied to the suture to position the graft at the desired location relative to the bone. The screw or plug is advanced into the pilot hole by turning the interference screw or tapping the plug until the cannulated screw or plug securely engages and locks in the eyelet implant, so that the cannulated plug or screw with the engaged eyelet implant is flush with the bone. Once the screw or plug is fully inserted and the suture is impacted into the bone, the driver is removed and any loose ends of the sutures protruding from the anchor site are then clipped short.

This is a continuation of U.S. application Ser. No. 13/765,218, filedFeb. 12, 2013, which is a divisional of U.S. application Ser. No.13/182,893, filed Jul. 14, 2011, now U.S. Pat. No. 8,430,909, which is acontinuation of U.S. application Ser. No. 12/022,868, filed Jan. 30,2008, now U.S. Pat. No. 7,993,369, which is a continuation-in-part ofU.S. application Ser. No. 10/405,707, filed Apr. 3, 2003, now U.S. Pat.No. 7,329,272, which is a continuation-in-part of U.S. application Ser.No. 09/886,280, filed Jun. 22, 2001, now U.S. Pat. No. 6,544,281, whichclaims the benefit of U.S. Provisional Application Ser. No. 60/213,263,filed Jun. 22, 2000.

FIELD OF THE INVENTION

The present invention relates to methods and instruments for fixation ofsutures and tissue to bone.

BACKGROUND OF THE INVENTION

When soft tissue such as a ligament or a tendon becomes detached from abone, surgery is usually required to reattach or reconstruct the tissue.Often, a tissue graft is attached to the bone to facilitate regrowth andpermanent attachment. Various fixation devices, including sutures,screws, staples, wedges, and plugs have been used in the past to securesoft tissue to bone. For example, in typical interference screwfixation, the graft is fixed to the bone by driving the screw into ablind hole or a tunnel in the bone while trapping the end of the graftbetween the screw and the bone tunnel. In other methods, the graft issimply pinned against the bone using staples or sutures tied around theend of the graft to the bone.

U.S. Pat. No. 6,544,281, the disclosure of which is incorporated byreference herein, discloses a surgical technique and associatedinstruments for securing soft tissue to bone which does not require thesurgeon to tie suture knots to secure the tissue to the bone. Accordingto the technique, a cannulated plug or screw is pre-loaded onto thedistal end of a cannulated driver, and a suture or wire loop is passedthrough the cannula of the driver so that a looped end of the suture orwire is exposed at the distal end of the driver. Suture strands attachedto a graft are fed through the loop at the end of the driver, and thedriver is inserted into the bottom of the hole, with the screw or plugdisposed just outside the hole. With tension applied to the suture orwire loop to keep the graft at the desired location relative to the bonehole, the screw or plug is then fully advanced into the hole using thedriver to frictionally secure either the suture attached to the graft orthe graft itself into the bone hole.

Although the above-described technique provides an improved method ofgraft fixation to bone, the flexible loop configuration at the end ofthe driver disadvantageously impedes sliding of the suture or graftwhich is fed through the suture loop. In addition, because thecannulated driver of U.S. Pat. No. 6,544,281 is provided with a flexibleloop at its distal end, placement of the suture or graft at the bottomof the blind hole or socket and the cortical bone must be approximated,thus sometimes necessitating additional removal, tapping and insertionsteps to ensure full insertion of the plug or screw into the blind holeor socket. This, in turn, may abrade the adjacent tissue and/or damagethe bone or cartilage.

Accordingly, a need exists for an improved surgical technique andassociated device for securing soft tissue to bone which allows the freesliding of the suture ends attached to a graft to ensure the positioningof the graft at an appropriate distance from the device. A fixationdevice and associated surgical technique that allow precise advancementand guiding of the plug or screw into the blind hole or socket are alsoneeded.

SUMMARY OF THE INVENTION

The instruments and methods of the present invention overcome thedisadvantages of the prior art, such as those noted above, by providingan eyelet implant at the distal end of a driver that securely engagesand locks into a cannulated ribbed body of an interference plug orscrew. The eyelet implant includes a fixed aperture for receiving asuture attached to a graft, such that the suture is able to freely slidethrough the aperture.

In one embodiment of the invention, suture is passed through the graftat desired points. A cannulated plug or screw is pre-loaded onto adriver provided with an eyelet implant at its distal end. Sutureattached to the graft is passed through an aperture of the eyeletimplant located at the distal end of the driver. The distal end of thedriver together with the eyelet implant is inserted directly into thebone. The screw or plug is fully advanced into the pilot hole by tappingthe interference screw or plug until the cannulated plug or screwsecurely engages and locks in the eyelet implant. Once the screw or plugis fully inserted and the suture is impacted into the bone, the driveris removed.

Other features and advantages of the invention will become apparent fromthe following description of the invention, which refers to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a distal end of a push lockdriver of the present invention.

FIG. 2 illustrates a perspective view of a push lock driver of thepresent invention.

FIG. 3 is a schematic cross-sectional view of a surgical site undergoinga graft fixation technique according to a method of the presentinvention.

FIG. 4 is a schematic view of the surgical site of FIG. 3 undergoing agraft fixation technique with the push lock driver of FIGS. 1-2.

FIG. 5 is a schematic view of the surgical site of FIG. 3 undergoing agraft fixation technique with the push lock driver of FIGS. 1-2 and at astage subsequent to that shown in FIG. 4.

FIG. 6 is a schematic view of the surgical site of FIG. 3 undergoing agraft fixation technique with the push lock driver of FIGS. 1-2 and at astage subsequent to that shown in FIG. 5.

FIG. 7 is a schematic view of the surgical site of FIG. 3 undergoing agraft fixation technique with the push lock driver of FIGS. 1-2 and at astage subsequent to that shown in FIG. 6.

FIG. 8 is a schematic view of an eyelet implant of the present inventionsecured by and locked into an interference device, and in accordancewith an embodiment of the present invention.

FIG. 9 illustrates a perspective view of a distal end of a push lockdriver in accordance with a second embodiment of the present invention.

FIG. 10 illustrates a perspective view of a distal end of a push lockdriver in accordance with a third embodiment of the present invention.

FIG. 11 illustrates a perspective view of a distal end of a push lockdriver in accordance with a fourth embodiment of the present invention.

FIG. 12 illustrates another perspective view of the push lock driver ofFIG. 11 with a strand passed through an aperture of the push lock.

FIG. 13 is a schematic cross-sectional view of a surgical siteundergoing a graft fixation technique with the push lock driver of FIGS.11 and 12.

FIGS. 14 and 14A are schematic views of the surgical site of FIG. 13 ata graft fixation stage subsequent to that shown in FIG. 13.

FIGS. 15 and 15A are schematic views of the surgical site of FIG. 13 ata graft fixation stage subsequent to that shown in FIGS. 14 and 14A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, where like elements are designated bylike reference numerals, FIGS. 1 and 2 illustrate an implant driver 100of the present invention. Driver 100 includes a body 4, preferably inthe form of a cylinder, and having a distal end 12 (FIG. 1) and aproximal end 13 (FIG. 2). The body 4 of driver 100 includes an outershaft 17 and an inner shaft 19. The outer shaft 17 is cannulated forreceiving inner shaft 19.

As illustrated in FIG. 1, driver 100 is pre-loaded with an interferencedevice 20. Preferably, the interference device 20 is a screw or aninterference plug, preferably formed of a bioabsorbable material such asPLLA. If a screw is employed, the screw may be provided with acannulated body provided with a continuous thread having rounded outeredges. The head of the screw may be rounded to minimize abrasion orcutting of tissue. The cannulation formed through the screw ispreferably hex-shaped and accepts the correspondingly shaped inner shaft19 of driver 100. If an interference plug is desired, the plug isprovided with rounded annular ribs separated by rounded annular grooves.The outer diameter of the ribs and grooves is substantially constant.The plug tapers significantly toward the distal end. The plug alsocomprises a cannula, preferably hex-shaped, for accommodating the innercorrespondingly shaped shaft 19 of the corresponding driver 100.

As also shown in FIG. 1, an eyelet implant 50 is provided at the distalend 12 of driver 100. The eyelet implant 50 is releasably attached tothe distal end 12 of driver 100 by means of a connector 57. The eyeletimplant 50 is formed of a transparent polymer material, and ispreferably made of a bioabsorbable material such as PLLA, polyglycolicor polylactic acid polymers. Advantageously, the eyelet implant 50 ismade of a material similar to that of the interference device 20. Asillustrated in FIG. 1, the eyelet implant 50 is provided with aperture55 for receiving a suture attached to a graft to pass through the eyeletimplant 50, as described in more detail below. The width “w” (FIG. 1) ofthe eyelet implant 50 is about equal the diameter of the inner shaft 19and slightly smaller than the diameter of the outer shaft 17 and of thecannula of the interference device 20.

FIG. 2 illustrates proximal end 13 of driver 100, showing a handle 15disposed coaxially with the body 4 and outer shaft 17 and provided withhandle slots or protuberances 16. As described below, handle slots orprotuberances 16 allow a suture strand to be wrapped around the handle15 and be subsequently tensioned prior to the impaction of theinterference device 20 into the pilot hole. In this manner, the graft isprecisely positioned at an appropriate distance from the pilot hole, andthe suture with the attached graft is secured at the bottom of the pilothole and prevented from exiting the pilot hole.

A method of a graft fixation technique according to the presentinvention is now described with reference to FIGS. 3-8. The presentinvention may be used to secure any type of soft tissue, graft, ortendon, such as, for example, a biceps tendon or a rotator cuff. FIG. 3illustrates at least one suture 80 passed though the graft 70 at desiredpoints. FIG. 3 also illustrates a pilot hole or socket 90 formed in thebone or cartilage 93 using a drill or punch, at the location where thetissue is to be secured. A punch provides the advantages of rounding theopening edge of the bone socket to protect the sutures 80 attached tothe graft 70 from being sheared during the insertion process, and alsocompacts the bone at the punch site for better attachment of the bone bythe anchor in cases where the bone is a soft bone.

Next, as shown in FIG. 4, driver 100 with a pre-loaded interferencedevice 20 and with the outer shaft 17 in the retracted position isprovided in the proximity of the bone socket 90. Sutures 80 attached tothe graft 70 are subsequently passed through the aperture 55 of theeyelet implant 50 at the end of driver 100, as shown in FIG. 4.

Referring now to FIG. 5, driver 100 is held with gentle pressure so thatthe eyelet implant 50 at the distal end 12 is held at the bottom of thehole 90, keeping the interference device 20 just outside the pilot hole90. Tension is then applied to the suture 80 by wrapping the suture 80around the slots 16 of the handle 15 and tensioning it, as shown inFIGS. 6-7. The suture 80 freely slides through aperture 55 of the eyeletimplant 50, allowing the graft 70 to be positioned close to the edge ofthe pilot hole 90. Once tensioning of the suture 80 has been completed,the interference device 20 is then impacted into the pilot hole 90 sothat the interference device 20 advances toward the distal end 12 ofdriver 100 and securely engages and locks in the eyelet implant 50 withthe sutures 80, as shown in FIGS. 7-8. After the interference device 20is fully inserted, the driver is removed and the ends of the sutures canbe removed by clipping them short, leaving the graft 70 securelyfastened to bone 93.

A significant advantage of the present invention is that the suturesattached to the graft or the graft itself can be securely attached tothe bone without the need to tie knots. Additionally, the sutureattached to the graft is secured both by the eyelet implant and by theinterference device, along the bottom and sidewalls of the pilot holebetween the bone and the screw or plug, conferring a much strongerfixation of the graft to the bone than is achievable with prior artprocedures and devices. More importantly, the suture attached to thegraft is allowed to freely slide though the aperture of the eyeletimplant to allow precise advancement and guiding of the plug or screwinto the blind hole or socket.

In another embodiment of the present invention illustrated in FIG. 9,driver 200 is provided with a horseshoe-shaped implant 250 (i.e., animplant with an open distal end) at the distal end of the driver in lieuof the eyelet implant. The horseshoe-shaped implant 250 is provided inthe form of a wedge 255 that allows the suture attached to a graft to besecurely contained within the wedge, yet be capable to freely slidewithin the wedge. The horseshoe-shaped implant 250 is formed of atransparent polymer material, and is preferably made of a bioabsorbablematerial such as PLLA, polyglycolic or polylactic acid polymers.Advantageously, the horseshoe-shaped implant 250 is made of a materialsimilar to that of the interference device 20.

The horseshoe-shaped implant 250 may be detachable from the distal end12 of the driver 200, similar to the eyelet implant described in detailabove. In this embodiment, the detachable horseshoe-shaped implant 250is securely engaged within the cannulated ribbed body of theinterference plug or screw 20. Alternatively, the horseshoe-shapedimplant 250 may be integral with the distal end 12 of the driver 200and, after the interference screw or plug 20 is fully inserted into thepilot hole, the horseshoe-shaped implant 250 is removed from the sitetogether with the driver 200.

In yet another embodiment of the present invention and as illustrated inFIG. 10, driver 300 of the present invention is provided with a metaltubing 350 at the distal end of a driver, which in turn, is providedwith a cut or pair of protuberances 355 at its most distal end to allowat least one end of a suture attached to a graft to be securelycontained within the cut, yet be capable to freely slide within the cut.Preferably, the metal tubing 350 is integral with the distal end 12 ofthe driver 300 and, subsequent to the full insertion of the interferencescrew or plug 20 into the pilot hole, the metal tubing 350 is removedfrom the site together with the driver 300.

FIGS. 11-15 illustrate another embodiment of the present invention,according to which driver 400 is provided with a pointed tip implant 450at the distal end of the driver, which is also an eyelet implant butwhich, because of its pointed tip, does not require the pre-drilling orpre-formation of a hole for fixating the device (implant with sutureattached to graft) in the bone. The conical configuration of the mostdistal end of the pointed tip implant 450 allows the driver 400 with theattached implant to undergo a self-punching operation during graftfixation, eliminating any need to pre-drill a hole in the bone andproviding increased fixation of the overall operation of securing thesoft tissue. The conical configuration of the most distal end of thepointed tip implant 450 also provides suture fixation strength, as wellas accelerated graft/tendon healing to bone. The pointed tip implant 450may be detachable from the driver.

As illustrated in FIGS. 11 and 12, pointed tip implant 450 is providedwith an eyelet or aperture 455 for receiving at least one strand (forexample, a suture strand) attached to a graft to pass through the eyeletimplant 450. Pointed tip implant 450 is also provided, at its mostdistal end, with a conical portion 451 which allows direct advancementof the implant (by simply tapping the device with a mallet, for example)without the formation of a bone hole. Preferably, the conical portion451 of the implant is formed of titanium or titanium alloy. In apreferred embodiment, eyelet or aperture 455 is also formed of titaniumor similar material, to withstand impaction forces during the graftfixation procedure.

As in the previously-described first embodiment, strand 80 (attached tograft 70) is passed through the aperture 455 of the implant 450 at theend of the driver 400, as shown in FIGS. 11 and 12. Although FIG. 12illustrate two strands 80 (i.e., two suture strands 80) passed throughthe aperture 455, the invention is not limited to this exemplaryembodiment and contemplates additional embodiments wherein one strand orany number of strands are passed through the aperture 455. Preferably,at least one of the strands is formed of a high strength suture materialsuch as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla., anddescribed in U.S. Pat. No. 6,716,234, the disclosure of which isincorporated by reference herein. The high strength suture may beavailable in various lengths and widths. FiberWire® suture is formed ofan advanced, high-strength fiber material, namely ultrahigh molecularweight polyethylene (UHMWPE), sold under the tradenames Spectra(Honeywell) and Dyneema (DSM), braided with at least one other fiber,natural or synthetic, to form lengths of suture material. The preferredFiberWire® suture includes a core within a hollow braided construct, thecore being a twisted yarn of UHMWPE. The suture may optionally includefilaments of various colors.

An exemplary method of graft fixation using the pointed tip implant 450of the present invention is illustrated with reference to FIGS. 13-15.This exemplary method illustrated in FIGS. 13-15 relates to a specificgraft fixation technique (i.e., SutureBridge Lateral Row fixation);however, the invention is not limited to this exemplary embodiment andapplies to any other method of soft tissue fixation known in the art.

Referring to FIG. 13, an Arthrex SutureBridge® medial row is completedas known in the art and the strands 80 (suture strands 80) are threadedthrough the titanium eyelet 455. As shown in FIG. 14A, a protective cap94 (or other device that prevents anchor deployment) is malleted toadvance the PushLock® until the anchor contacts bone 93. The suture isthen tensioned, as shown in FIG. 14. The protective cap 94 issubsequently removed (FIG. 15A) and the plug 420 is malleted until amark (for example, a predefined laser line) is flush with the bone (FIG.15). The ribbed, spiked configuration of plug 420 facilitates theinsertion of the device 400 into the bone by simply exerting force uponthe device, without the need to drill or form a hole in the bone.

Although the above embodiments have been described with reference to animplant, such as eyelet implant 50, 450 (FIGS. 1 and 11) orhorseshoe-shaped implant 250 (FIG. 9), for example, having an apertureof a predefined configuration (i.e., eyelet or horseshoe configuration),it should be understood that the invention is not limited to theseembodiments. Accordingly, the present invention also contemplatesimplants affixed to or detachable from a preloaded driver and having anaperture of any configuration or geometrical shape, as long as itcaptures suture and allows the captured suture to freely slide withinthe aperture.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art. It ispreferred, therefore, that the present invention be limited not by thespecific disclosure herein, but only by the appended claims.

What is claimed is:
 1. A method of soft tissue repair, comprising thesteps of: providing a hole in a bone at a location at which a softtissue graft is to be affixed; attaching at least one suture to the softtissue graft to be affixed; capturing the suture attached to the graftby feeding the suture through an aperture of an implant, said implantbeing releasably attached at a distal end of a driver, the driver beingpreloaded with a cannulated interference device on a shaft of thedriver; inserting the suture into the hole by inserting the distal endof the driver into the hole; pulling on one end of the suture to drawthe suture through the aperture of the implant such that the soft tissuegraft attached to the suture is drawn toward the hole; and inserting theinterference device into the hole so that the cannulated interferencedevice is advanced toward the implant to secure the suture in the hole.2. The method of soft tissue repair according to claim 1, wherein theinterference device is a screw.
 3. The method of soft tissue repairaccording to claim 1, wherein the interference device is a plug.
 4. Themethod of soft tissue repair according to claim 1, wherein the aperturehas an eyelet configuration.
 5. The method of soft tissue repairaccording to claim 1, wherein the aperture has a horseshoe-shapedconfiguration.
 6. The method of soft tissue repair according to claim 1,wherein the aperture is provided with at least one protuberance at itsdistal end.
 7. The method of soft tissue repair according to claim 1,wherein the driver includes an outer shaft disposed around an innershaft and movable between a proximal position and a distal positionalong the inner shaft, and wherein the interference device is preloadedonto the inner shaft by inserting the inner shaft through a cannula ofthe interference device with the outer shaft retracted to the proximalposition so that the proximal end of the loaded interference deviceabuts the distal end of the outer shaft.
 8. The method of soft tissuerepair according to claim 7, wherein the interference device is a screwhaving a hex-shaped cannula and at least a portion of the implant at thedistal end of the driver is hex-shaped to be matingly insertable intothe hex-shaped interference screw cannula.
 9. The method of soft tissuerepair according to claim 1, wherein the soft tissue graft is drawn intothe hole by pulling on the suture, and the interference device securesnot only the suture but also the graft in the hole.
 10. The method ofsoft tissue repair according to claim 1, wherein the interference deviceis inserted into the hole by impaction.